7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
STABLELINE
FDA 510(k)
FDA Class 1
·Cardiovascular
SUPPORT, WRIST, FIRM WIRE-FOAM
FDA 510(k)
FDA Class 1
·Physical Medicine
PILL PHONE
FDA 510(k)
FDA Class 1
·Physical Medicine
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MPRI·Product code LWS·June 10, 2014
PONTO IMPLANT WITH ABUTMENT
FDA Adverse Event
Other
·OTICON MEDICAL AB·Product code LXB·November 29, 2012
ISERT ASPHERIC INTRAOCULAR LENS
FDA Adverse Event
Malfunction
·HOYA SURGICAL OPTICS INC.·Product code HQL·September 23, 2010
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012